Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Not Applicable

Completed

• Conditions: Colorectal Adenomas; Colorectal Polyps
• Interventions: Device: Arc Endocuff (AEC 110, 120, 130, 140); Device: Cap; Device: Standard colonoscope

• Registration Number: NCT02331836
• Lead Sponsor: Helios Albert-Schweitzer-Klinik Northeim

Brief Summary

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed Description

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Study Timeline

• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Study Start: 2015-02
• Status Verified: 2019-02
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

• Colonoscopy independent from indication
• Age ≥ 18
• Patient is able to provide informed consent for the procedure

Exclusion Criteria

• Inflammatory Bowel Disease stenosis
• Pregnant of nursing patient
• Acute diverticulitis
• Active Inflammatory Bowel Disease
• Age ≤ 18
• Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Arc Endocuff (AEC 110, 120, 130, 140)	Arc Endocuff (AEC 110, 120, 130, 140)	Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope
Cap	Cap	Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope
Standard Colonoscope	Standard colonoscope	Standard colonoscopy without any additional device

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	1 year	Proportion of patients having at least one adenoma
Polyp detection rate	1 year	Proportion of patients having at least one adenoma

Secondary Outcome Measures

Name	Time	Method
perforation	one day
Ileum intubation rate	one year
withdrawal time	one day
mucosal laceration	one day
severe bleeding	one day
Bowel preparation result	one day
Coecum intubation rate	one year
Coecum intubation time	one day

Trial Locations

Locations (6)

University Medical Center Göttingen; 🇩🇪 Göttingen, Germany

HELIOS St. Marienberg Klinik Helmstedt; 🇩🇪 Helmstedt, Germany

University of Muenster; 🇩🇪 Muenster, North-Rhine Westphalia, Germany

HELIOS Albert-Schweitzer-Klinik; 🇩🇪 Northeim, Germany

HELIOS Medical Center Siegburg; 🇩🇪 Siegburg, Germany

Wroclaw Medical University; 🇵🇱 Wroclaw, Poland